Rx COOL
Problems with drug imports in recent years, most notably contaminated heparin from China that resulted in the deaths of 19 individuals, has led to growing calls for the government to mandate country of origin labeling (COOL) for pharmaceuticals.
Today, the Food and Drug Administration (FDA) requires drug companies to disclose the name and place of the manufacturer or distributor of prescription medicines along with a list of ingredients (active and inactive). Raw materials, however, are not listed.
Companies involved in the pharmaceutical business contend that including a listing and source of raw materials is impractical and would not improve the overall safety of the supply chain. All drugs sold in the U.S., COOL opponents point out, must conform to Good Manufacturing Practices set by the FDA.
“The requirements, if it’s made in Nutley, N.J., or a foreign country, are exactly the same,” says Lori Reilly, vice president for policy and research at Pharmaceutical Research and Manufacturers of America, told The Wall Street Journal.
The problem, contend critics of the present system, is that neither pharmaceutical companies nor the FDA do a sufficient job of inspecting overseas factories. Raw materials or finished product that come into the U.S. are assumed to meet manufacturing guidelines.
According to The Journal article, 80 percent of active ingredients used in U.S. prescription drugs now come from facilities outside the country. The House Energy and Commerce Committee is looking at amending a bill to increase the number of inspections the FDA conducts of overseas factories as well as adding requirement for COOL for active ingredients in drugs.
The FDA has not come out in support of new labeling requirements.
“What level of detail would be meaningful to consumers,” Karen Riley, an FDA spokesperson asked The Journal. “What does it mean that most heparin in the world is coming from China and you need heparin?”
Discussion Questions: What would you say is the level of confidence that American consumers have in the combined safety and effectiveness of prescription medicines sold in retail pharmacies today? Is a country of origin labeling requirement for active ingredients in pharmaceuticals something the retail industry should support?
Isn’t COOL just another form of xenophobia? We need State Of Origin Labeling. The biggest meat recall originated in New Jersey. Shoppers want to know if their meat comes from New Jersey packing plants. Country Of Origin Labeling doesn’t go far enough. We need STOOL.
What’s a consumer supposed to do with COOL information? Decline the medication? Request a (nonexistent) version manufactured in a different country, based on their (nonexistent) pharmaceutical expertise?
Consumer distrust of pharmaceuticals is a big problem for drug companies (and their stockholders). Mandating COOL may look good on paper but is hardly the answer since probably 95% of the packages would have to say “China” which is far from reassuring to most. To expect the US government to inspect all drugs and drug ingredients at the foreign source, or when coming into the country (in their spare time after examining toys, fish, toothpaste, etc.) is folly and far from the Founders’ ideas of the role of the Federal Government.
It should fall on the drug companies selling the product in the USA to do whatever is necessary to protect their brand and assure the quality of their product based on safety standards. The Government’s role should be to “incent” safety, by legislating draconian fines and sanctions that will make the companies’ lives unconditionally miserable if they fail to ensure safe products. Of course, this issue alone will provide full employment for pharmaceutical lobbyists for years to come.
People who are sick should not have the additional stress of wondering if the medicines they are taking for the illness may instead kill them.
I have frequently gone on record in favour of COOL on the basis that people should be entitled to make informed decisions. In the case of prescription medication, however, even I have to recognise that this is neither practical nor the best way of ensuring product safety. I am, therefore, pretty much in agreement with everyone else.
The money that would be spent in attempting to list the country of origin of the multiple ingredients would be put to much better use ensuring that the ingredients separately, and together, are checked for safety. Even if they were labeled, people would have little choice as to whether or not to buy them. Lack of trust is probably justified–demonstrating that drug manufacturers and government inspectors can be trusted is far more important. And demonstrating is the operative word here–assertions are not enough, some form of proof to justify claims must be devised although I haven’t a clue how to do it.
US consumers are being buffeted by multiple food and drug scares. Consumers want to know that what they put into their bodies is safe. Government needs to respond to this quickly and forcefully. Putting sole responsibility on manufactures is not the answer. Manufacturers must take responsibility, and government must back up that responsibility with legislation that has some real teeth.
Country of origin is not the problem. We live in a global economy and need to learn how to operate in such. It is the responsibility of the manufacturer to make sure their products meet their specification and are safe. Just like the security issues in Rx, the manufacturer must make sure all components are specified correctly and suppliers adhere to this standard.
US manufacturers must get out of the American business mind set and realize that they operate in a global market place. For example, just because a chemical has not been used the US for 30 years does not mean it is not available in the rest of the world. Manufacturers must implement raw material testing, batch testing and finished product testing for everything.
David is quite right. Unfortunately, there is little or no oversight on any of these components. Country-of-origin labeling on drugs is fine. But what choice do consumers really have? What we need is greater government oversight and have the pharmaceutical companies do a better job of policing their own suppliers.
What most of the public doesn’t realize is that many products have origins from multiple countries. One ingredient might originate in one place, while another ingredient or component comes from another. Therefore, any labeling requirements could be convoluted or misleading.
Country of origin is a must. As a practicing pharmacist for 38 years, I have, with confidence, dispensed both brand and generic drugs. With the cutbacks at FDA and the problems we’ve already had with products from certain countries, COOL is a must. Congress must increase funding of the FDA and the FDA in turn must step up domestic and foreign inspection.